CTIS Coordinator
- Poland
- Study Start Up
- ICON Strategic Solutions
- Remote
Principal Talent Acquisition Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please click here to view live vacancies.
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Regulatory Submission Manager is responsible for coordinating the operational and strategic aspects of clinical trial submissions applicable for countries in scope of the EU CTR for internally managed, and/or outsourced, trials, including compound level coordination. They co-ordinate the EU CTR operational clinical trial submission strategy - and develops, drives and monitors timelines/milestones. They work with central teams and country teams to ensure all information and documentation for submission to the EMA Clinical Trial Information System (CTIS) are completed and performed on a timely and compliant basis.
Responsibilities include planning a compound and trial level EU CTR combined operational submissions strategy with relevant cross-functional involvement throughout the entire trial lifecycle. This role will be responsible for driving the discussions, consolidate input from all stakeholders and facilitate discussions via scenario planning with a view to agree the final EU CTR submission strategy. In addition, this role will be responsible for coordinating submissions in the CTIS portal.
This position interfaces with stakeholders internal and external to Global Operations functions, such as the CTIS Administrator, GCO Country Local Submission Coordinator (local point-of-contact), Clinical Trial Manager (CTM), Global development Trial Leader (GTL), Global Regulatory Clinical Trial Application Submissions Manager (Global CTA SM), CRO point of contact, and other relevant functional area stakeholders as needed. They collaborate closely with the GTL, CTM (if applicable), LPOC and CTA SM, and are a member of the Trial Team.
Major Duties/Responsibilities operations
•Lead the EU Submission strategy development, planning and delivery as a member of the Cross Functional Trial Team (CFTT)
•Clinical trial planning, submissions and notifications
•Financial planning and tracking
•Cross functional submission management
•Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
•BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
•Required: Global clinical research regulation knowledge and understanding, strong project planning/management expertise and effective communication skills.
•Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.
•Proven track record in successfully managing multinational clinical trial submissions to Health Authorities and or/ Ethics Committees.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
Similar jobs at ICON
Salary
Location
Bulgaria, Sofia
Location
Sofia
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Role Summary:The Site Selection lead will provide functional leadership for the Site Selection process based on the approved country and site strategy. The Site Selection Lead will liaise with PM, CTM
Reference
JR128704
Expiry date
01/01/0001
Author
Jaziara HancoxAuthor
Jaziara HancoxSalary
Location
Canada
Department
Study Start Up
Location
Canada
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
As a Site Activation Partner you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Le partenaire d'activation du centre de l’
Reference
2025-119828
Expiry date
01/01/0001
Author
Brendan HoeyAuthor
Brendan HoeySalary
Location
US, New York, NY, Rochester
Department
Full Service - Development & Commercialisation Solutions
Location
Blue Bell
Rochester
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Sr. Study Support Assistant - Imaging - Hybrid (60% office/40% remote)The Sr. Study Support Assistant is responsible for assigned project site start-up and qualification activities per study specific
Reference
JR130727
Expiry date
01/01/0001
Author
Kris CostelloAuthor
Kris CostelloSalary
Location
Ireland, Dublin
Department
Full Service - Development & Commercialisation Solutions
Location
Dublin
Swansea
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
The Senior Study Support Assistant is responsible for assigned project site start-up and qualification activities per study specific requirements. Additionally, the Senior Study Support Assistant will
Reference
JR130731
Expiry date
01/01/0001
Author
James SmithAuthor
James SmithSalary
Location
Argentina
Department
Study Start Up
Location
Argentina
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
The Study Start-Up Associate performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accorda
Reference
2025-119739
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Mexico, Mexico City
Location
Sao Paulo
Santiago
Bogota
Mexico City
Lima
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Site Activation
Job Type
Permanent
Description
We are currently seeking a Site Activation Lead to join our diverse and dynamic team. As a Site Activation Lead at ICON, you will advance clinical trial start-up activities by understanding client obj
Reference
JR129331
Expiry date
01/01/0001
Author
Florencia Borello TaianaAuthor
Florencia Borello Taiana